Continuous Wearable Monitor for the Detection and Release of Freezing of Gait. (NCT06385392) | Clinical Trial Compass
CompletedNot Applicable
Continuous Wearable Monitor for the Detection and Release of Freezing of Gait.
United States31 participantsStarted 2024-09-11
Plain-language summary
The proposed system (haptic module and insole device) for daily in-community use that detects the occurrence of freezing of gait (FOG) in people with Parkinson's disease (PD). and triggers external cueing stimuli to unfreeze the individual. The purpose of the overall Phase II study is to: (1) Develop a production ready system, (2) Develop a companion mobile app for the proposed system and refine previously developed FOG detection algorithms, and (3) Validate the proper operation of the system and demonstrate its efficacy through lab and in-community testing. This study will focus on validating the system and demonstrating efficacy through in-community testing.
Who can participate
Age range
45 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Ability to provide and provision of signed and dated informed consent form.
* Age 45 or older
* Diagnosis of idiopathic PD, as determined by a movement disorders neurologist in accordance with the PD Society Brain Bank diagnostic criteria.
* Evidence of presence of freezing gait as a symptom. Determined from combination of clinical examination (observation of freezing) and New Freezing of Gait Questionnaire (NFOG).
* Able to complete a 2-minute walk test at the pre-treatment visit.
* Currently on a stable prescription medication regimen for PD and willing to adhere to the regimen during the study.
* Ability to don and doff the insole and haptic module independently or have daily assistance during the study intervention.
Exclusion Criteria:
* Non-English speaking
* History of musculoskeletal disorders that significantly affect movement of lower limbs as determined at the time of enrollment.
* Other significant neurological disorders that may affect participation or performance in the study.
* Neuropathy at the ankle assessed at the pre-treatment visit using the haptic module.
* Hallucinations
* Non-ambulatory
* Legally Blind
* Symptomatic hypotension
* Any condition which would limit sensation in the legs or requires use of wraps, bandages or other items which may limit sensation in the legs (e.g., lymphedema) that would interfere with the performance of the haptic device, in the opinion of the investigator.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To Validate the Haptic Module and Insole Device System and Evaluate Its Efficacy With an In-community Clinical Trial.